Device Problem
Insufficient Information (3190)
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Patient Problem
Insufficient Information (4580)
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Event Date 03/06/2024 |
Event Type
malfunction
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Event Description
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Consumer left an amazon review for inteliswab claiming false negative results.Amazon review: 'test does not work.I did two tests today.One with intelliswab and the other with s known quality brand, flowflex.I still have mild fever.Obviously the former test sux.The latter test is reliable.Buyer beware.' refer to attached amazon review and photos showing a negative inteliswab test and a positive flowflex test.
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Event Description
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Consumer left an amazon review for inteliswab claiming false negative results.Amazon review: 'test does not work.I did two tests today.One with intelliswab and the other with s known quality brand, flowflex.I still have mild fever.Obviously the former test sux.The latter test is reliable.Buyer beware.' refer to attached amazon review and photos showing a negative inteliswab test and a positive flowflex test.
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Manufacturer Narrative
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The consumer reported false negative inteliswab test results in their amazon.Com review.Specific details of the collection and testing process of the inteliswab tests were not provided.The consumer also did not provide a lot number or any other product information.It is unknown if a pcr test was used to confirm the test results.Orasure technologies, inc.Is unable to contact the consumer for additional information as no contact information is available on amazon.Com.No additional follow up is to be expected with this complaint and the incident will be closed internally.
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Search Alerts/Recalls
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